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NCT05744739
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
Phase 1 trial testing Biospecimen Collection in Acute Myeloid Leukemia in 15 participants. Participants enrolled and being followed up; not accepting new ones.
20 August 2024
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 29 September 2023 |
| Primary completion | 20 August 2024 |
| Estimated completion | 23 April 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Tomivosertib — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
Northwestern University
Who can join
18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase 1 of the study will open first with a (Bayesian optimal interval BOIN) dose finding design. The starting dose of tomivosertib is 100mgdaily (doses 24 ± 2 hours apart), PO, self-administered with meals. The dose finding follows a BOIN design, with the 100mg BID dose level with a meal being the highest dose. There is one dose level below (dose level -1 = 100mg QD without a meal) that will be given if the de-escalation condition is met during dose finding. Upon completion of the phase 1 dose finding portion of the study, the recommended starting dose of tomivosertib for the subsequent combination with the other agents will be determined, as described in Section 4.3 and Section 8.0. Tomivosertib will be dosed continuously on days 1-28 of each 28-day cycle at the dose level assigned for that cohort.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Blocking tumor-intrinsic MNK1 kinase restricts metabolic adaptation and diminishes liver metastasis.
Preston SEJ, Dahabieh MS, Flores González RE, Gonçalves C, et al · · 2024 · cited 4× · PMID 39270021 · DOI 10.1126/sciadv.adi7673
Verify or expand the search:
- PubMed search for NCT05744739
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05744739 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwestern University
- Last refreshed: 21 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05744739.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing